A Clinical Trial Evaluating the Safety and Efficacy of Intravenous HNF4α SrRNA in Treating Metastatic CRC Patients
Trial Parameters
Brief Summary
This trial is a single-arm, open-label, exploratory first-in-human clinical study designed to evaluate the safety and tolerability of HNF4α srRNA injection in patients with locally unresectable or metastatic colorectal cancer, and to preliminarily explore its effectiveness in treating metastatic colorectal cancer.
Eligibility Criteria
Inclusion Criteria: 1. Males or females, aged 18 years or older. 2. Patients with histologically confirmed colorectal cancer that has been determined to be unresectable or metastatic. 3. Colorectal cancer subjects who are unsuitable or unable to tolerate standard systemic therapy, or who have received standard systemic therapy but have disease progression based on RECIST (version 1.1) criteria, including chemotherapy based on fluorouracil, oxaliplatin, or irinotecan, and targeted therapies with anti-VEGF/EGFR monoclonal antibodies. 4. Patients with confirmed deficient mismatch repair (dMMR) or high microsatellite instability (MSI-H) in tumor tissue, who have been treated with immune checkpoint inhibitors (anti-PD-1 or anti-PD-L1 antibodies) and are assessed with disease progression. 5. According to the RECIST (version 1.1) criteria, there are measurable target lesions suitable for repeated measurements for assessment. 6. Life expectancy of 12 weeks or more. 7. Subjects must have an Eas